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Significant innovation in disease treatment, including the increased focus on complex biologic therapies1, has resulted in important industry trends that have had an impact on many aspects of aseptic processing.

While the requirements for serialization in the pharmaceutical supply chain are generally regarded as inevitable counterfeiting is simply too large of a problem to not be addressed there is some uncertainty around the specifics,particularly globally.

Patient recruitment is often cited as one of the biggest challenges faced by clinical trial professionals. Many clinical trials fail because sponsors cannot recruit sufficient patients to reach their target sample size[1,2].

Digital technology has been driving change throughout the life science industry for years, however the sector is currently standing on the precipice of revolutionary development – some organizations have already taken the jump towards a more digital future.

The Falsified Medicines Directive 2011/62/EU, which is due for adoption in February 2019, will require pharmaceuticalcompanies to apply serialisation codes to every applicable pack (OTC and some minor exemptions).

When it comes to the manufacturing of drugs, particularly highly sensitive biologics, a high-level of expertise is required. Typically, small and medium-sized pharma and biotech companies lack the knowledge and know-how necessary to cover all the processes independently prior to completion of the entire final product.

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Upcoming Events

News & Press Releases

Drug Safety 2018 aims to discuss the latest findings and current thinking on pharmacovigilance. Importantly, it will address the newest regulatory updates and interpretations of them, including the impact of the vital and much awaited Clinical Trial Regulations.

SMi are delighted to have our Chairman, Speaker and Workshop Host, Justin Mason-Home, Director, HPAPI Project Services Limited, onto the speaker panel for HPAPI 2018!

AstraZeneca presented new post-progression outcomes data from an exploratory analysis of the global Phase III FLAURA trial, which assessed the efficacy and safety of Tagrisso (osimertinib) as 1st-line therapy in patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC).

The 6th annual conference will gather the growing freeze drying community, filled with industry thought leaders and principle scientists involved in: manufacturing, material sciences, bio-therapeutics and pharmaceutical engineering.

SMi are delighted to have interviewed our speaker Maxime Gaillot, Senior Device Engineer, Roche, for Injectable Drug Delivery!

TraceLink Inc., the World’s Largest Track and Trace Network for connecting the life sciences supply chain and providing real-time information sharing for better patient outcomes, announced EU FMD Express – a cost-effective, simplified solution designed specifically to address the needs of smaller pharmaceutical companies complying with the EU Falsified Medicines Directive (FMD.)

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IDIFARMA has announced new GMP spray drying capabilities which will make it one of the very few contract development and manufacturing organisations (CDMO) to offer spray drying technology for highly potent drugs up to Category 4 OEL/OEB.

Roche Holding AG (ROG.EB) said that a phase 3 IMpower150 study showed an improvement in the treatment of advanced lung cancer with the use of Tecentriq.

The Johnson & Johnson Human Performance Institute today announced it is expanding its footprint in the Lake Nona community in Orlando, Florida with the construction of its new global headquarters.

Nordic Nanovector ASA announces that a poster reporting the anti-tumour effect of Humalutin® (177Lu-conjugated humanized anti-CD37 antibody, 177Lu-NNV003) in preclinical models of non-Hodgkin's lymphoma (NHL) was presented yesterday at the American Association of Cancer Research (AACR) Annual Meeting 2018 in Chicago, USA.

Apitope, a clinical stage biotech company developing potential first-in-class antigen-specific immunotherapies targeting autoimmune diseases (including multiple sclerosis (MS), Graves' disease and uveitis), announced positive results from the Phase I first in man clinical trial of its product candidate, ATX-GD-59, in development for the treatment of Graves' disease.

The U.S. FDA  approved Sanofi's Toujeo® (insulin glargine 300 Units/mL) Max SoloStar®, the highest capacity long-acting insulin pen that will be available on the market.

Medical technology company IME Technologies, developer, producer and scientific partner in the field of biomedical electro spinning processes and equipment, has moved its operations from Geldrop to a significantly larger facility in Waalre with effect from 26 March.

Switzerland-based contract development and manufacturing organisation (CDMO) Micro-Sphere has successfully completed the Swissmedic inspection of its expanded facility, resulting in the renewal of its GMP approved status and increased manufacturing capacity.

The deal gives Ipsen access to Arix’ network of professional and scientific advisors, and the chance to invest in the firm’s new and existing businesses.

At Achema 2018, Bosch Packaging Technology presents a fast high-precision capsule filling machine for small batches.

Horizontal cylindrical chamber autoclaves manufactured by Priorclave are among the most energy efficient laboratory autoclaves currently available. 

At Achema 2018, Bosch Packaging Technology presents its R&D, line and service competence, complemented by comprehensive Industry 4.0 solutions.